Anika Therapeutics Submits Regulatory Application For Cingal

Anika Therapeutics, Inc.

, a leader in products for tissue protection, healing and repair, based on hyaluronic acid (HA) technology, today announced that it has filed regulatory submissions in both the United States and Europe seeking the approval of Cingal, the Company's novel HA plus steroid single-injection treatment for osteoarthritis of the knee. Anika submitted its application for CE Mark approval to commercialize Cingal in the European Union and also filed its premarket approval application (PMA) with the U.S. Food and Drug Administration to allow for marketing and distribution in the United States. "After meeting all of the primary and secondary endpoints from our multinational Phase III Cingal clinical trial in a clinically and statistically meaningful fashion, we filed the CE Mark application as planned at the end of 2014 and submitted the PMA a few days ago, ahead of schedule," said Anika President and CEO Dr. Charles H. Sherwood. "The filing of these submissions is a milestone achievement for Anika and, after approvals, positions us extremely well in the market from a competitive standpoint. In addition to the United States and Europe, we plan to commercialize Cingal in other key markets in the world. We look forward to patients benefiting from Cingal, which provides the convenience and efficacy of our current single-injection treatment, Monovisc^®, with the added early symptom relief benefits of a commonly used steroid." The Cingal Phase III trial was a 26-week, randomized, double-blind, three-arm, placebo-controlled study designed to evaluate the efficacy and safety of a single injection of Cingal in approximately 368 patients experiencing joint pain from osteoarthritis of the knee who had not responded to conservative treatment. Patients were randomized to receive a Cingal treatment, a placebo treatment or a treatment of Anika's Monovisc product. After the initial treatment, patients were assessed for 26 weeks at clinical sites in Europe and Canada. The primary clinical effectiveness endpoint data measured the change in the patients' knee pain over the course of the trial from their baseline level according to the WOMAC Pain Score.